Efficacy and safety of golimumab biosimilar BAT2506 in patients with active psoriatic arthritis after switching from reference golimumab: 52-week results of a phase 3, double-blind, randomized study.

BACKGROUND: Switching from a reference biologic to a biosimilar can offer patients similar safety and efficacy while reducing healthcare costs and increasing treatment access. We report long-term efficacy and safety while switching from reference golimumab (Simponi; Ref-GLM) to BAT2506 in patients with active psoriatic arthritis during Treatment Period 2 (TP2; Week 24-52) of a confirmatory phase 3 study. RESEARCH DESIGN AND METHODS: Patients were randomized (1:2:1) to subcutaneous administration of Ref-GLM every 4 weeks to Week 48 (Ref-GLM group), or BAT2506 to Week 48 (BAT2506 group), or Ref-GLM to Week 24 followed by BAT2506 to Week 48 (Ref-GLM/BAT2506 group). Patients who completed TP1 at Week 24 entered TP2. Assessments through Week 52 included American College of Rheumatology 20/50/70 responses, disease activity score-28 C-reactive protein, safety, serum drug concentrations, anti-drug antibody, and neutralizing antibody incidence. RESULTS: 679 patients entered TP2. At Week 52, the efficacy endpoints showed no differences across any of the treatment groups. The incidence of treatment-emergent adverse events was comparable across groups, with no new safety signals. Pharmacokinetics (PK) profiles overlapped, and immunogenicity was comparable. CONCLUSIONS: Switching from Ref-GLM to BAT2506 showed comparable efficacy, safety, immunogenicity, and PK profiles to continued treatment with BAT2506 or Ref-GLM. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov identifier is NCT05046431.